Registered Kenya · PPB

BARICINIX 2MG TABLET

BARICINITIB

H2022/CTD9293/20784 BARICITINIB INN 2MG GENERIC/BIOSIMILARS

What it does

Baricitinib is a medication used to treat certain autoimmune disorders by reducing inflammation in the body.

Commonly used for: rheumatoid arthritis, atopic dermatitis

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2022/CTD9293/20784
Registration date
-
Expiry date
2027 November 08
Status
Registered
Active ingredient
BARICINITIB
Dosage form
BARICITINIB INN 2MG
Strength
-
Pack size
1X30'S IN HDPE BOTTLE
Therapeutic class
GENERIC/BIOSIMILARS
Manufacturer / MAH
Generics Africa
Applicant / LTR
BEACON MEDICARE LTD
Country of origin
FOREIGN
Manufacturer location
Generics Africa Limited, RAFIKI BUSINESS PARK, OFF THIKA SUPER HIGHWAY, RING ROAD, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:38:56 · updated 2026-10-23 02:29:29

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Baricitinib is a medication used to treat certain autoimmune disorders by reducing inflammation in the body.

What it treats

  • rheumatoid arthritis
  • atopic dermatitis

How it works

It works by blocking specific enzymes that contribute to inflammation and immune responses.

Who it's for

This medicine is for adults with moderate to severe autoimmune diseases that haven't responded well to other treatments.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: baricinitib

Baricitinib is an oral Janus kinase (JAK) inhibitor that is primarily used for the treatment of moderate to severe rheumatoid arthritis in adults and has also been explored for other inflammatory conditions. By inhibiting JAK1 and JAK2, baricitinib modulates the immune response, thus reducing inflammation and providing relief from symptoms associated with autoimmune diseases.

Indications

  • Moderate to severe rheumatoid arthritis
  • Atopic dermatitis (in certain cases)
  • Other inflammatory conditions as determined by clinical need

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations for paediatric patients, as dosing may vary significantly based on age and weight.

Adults: Refer to the BNF for specific dosing recommendations based on the condition being treated, severity of the disease, and patient characteristics.

Mechanism of action

Baricitinib selectively inhibits Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2). These kinases are involved in the signaling pathways of various cytokines and growth factors that are crucial for the inflammatory response. By blocking these pathways, baricitinib decreases the production of pro-inflammatory mediators and alters the immune response.

Pharmacodynamics

The pharmacodynamics of baricitinib involve the suppression of the JAK-STAT signaling pathway, which is essential for the function of several cytokines. This leads to a reduction in the activation and proliferation of lymphocytes, decreased production of inflammatory markers, and overall modulation of the immune response, contributing to symptomatic relief in autoimmune disorders.

Pharmacokinetics

Baricitinib is well absorbed following oral administration and reaches peak plasma concentrations within 1 to 2 hours. It has a volume of distribution that suggests extensive tissue distribution. Baricitinib is primarily metabolized by the liver, with a half-life of approximately 12 hours, allowing for once-daily dosing. The drug is eliminated mainly through renal pathways, necessitating dose adjustments in patients with renal impairment.

Contra-indications

  • Active tuberculosis
  • Serious infections
  • Severe hepatic impairment
  • Hypersensitivity to baricitinib or any component of the formulation

Adverse effects

  • Increased risk of serious infections
  • Thrombosis
  • Elevated liver enzymes
  • Gastrointestinal perforation
  • Headache
  • Nausea
  • Fatigue
  • Anemia

Interactions

  • CYP3A4 inhibitors may increase baricitinib levels
  • CYP3A4 inducers may decrease baricitinib levels
  • Live vaccines should be avoided during treatment

Precautions

  • Monitor for signs of infection
  • Assess for risk factors of thrombosis
  • Evaluate liver function prior to and during treatment
  • Consider risk of gastrointestinal perforation in patients with a history of diverticulitis

Pregnancy

Baricitinib is not recommended during pregnancy due to potential risks to the fetus. Women of childbearing potential should use effective contraception during treatment.

Breast-feeding

It is unknown whether baricitinib is excreted in human milk. Caution should be exercised when administering to breastfeeding women.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Oral tablet

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.